Prefilled syringes, such as the Abboject.RTM. Unit of Use Emergency Syringe sold by Abbott Laboratories, are used for both direct and indirect injections into a patient. For example, the sharp needle can be used for hypodermic injections directly through the patient's skin. The same sharp needle can be used for infusions into a standard reseal on an intravenous administration tubing set having a venous access catheter to the patient.
The Abboject Syringe system includes a calibrated glass vial prefilled with a medical solution and a mating vial injector. The vial injector (or syringe housing) traditionally includes an integral, forward extending sharp delivery needle that can be used to inject the medical solution directly into a patient or into a reseal on an I.V. administration set connected to a patient. The traditional Abboject syringe is assembled with the delivery needle enclosed by a removable needle cover to protect against accidental needle stick prior to use. The cover also protects the sterile needle from contamination prior to use.
Patients and healthcare workers are sensitive to the danger of accidental needle stick from exposed sharp needles. Blood borne diseases such as AIDS and hepatitis can be transmitted by accidental needle sticks from sharp needles previously in contact with an infected patient's blood system.
Currently there are many efforts to reduce the number of exposed sharp needles in the healthcare environment, especially in emergency situations. The efforts include making one initial venous entry with a catheter into the patient's blood system and then providing a connecting I.V. administration set with reusable and/or multiple access sites. This procedure minimizes the need for direct injections and potential contact with the patient's blood system. Another effort is to provide removable and/or permanent needle guards such as the Lifeshield.RTM. Abboject.RTM. Emergency Syringe with Needle Guard, sold by Abbott Laboratories. These guarded needle syringes are used in place of unguarded needles when sharp needle syringes are absolutely necessary. Further efforts include using blunt cannula with prepierced reseals for I.V. connections rather than traditional sharp needles and pierceable reseals. Alternatively, luer fitment connections are used in I.V. set connections in place of sharp needles and reseals.
In addition to emergency syringes, prefilled syringes are used for routine procedures such as therapeutic drug administration. This casual use may expose the healthcare worker to an additional type of accidental needle stick. Besides a life-threatening blood infection that may have infiltrated from the patient's blood system, the worker may be exposed to the side effects of drug residual in the needle, such as an oncology drug.
An example of a protective sheath and cap for a syringe needle is shown in U.S. Pat. No. 4,232,669 to Nitshke. The syringe is intended for use with an additive port of a flexible bag and therefore the sheath does not extend beyond the needle point. The sheath and a removable protective cap maintains the sterility of the syringe needle. However, the health care worker is at risk of accidental needle stick when the protective cap is removed. The sheath of Nitshke is attached to the syringe by an collar engaging the needle hub. Therefore a protective sheath similar to the sheath suggested by Nitshke could not be added to the standard Abboject Syringe without extensively redesigning the syringe and the syringe manufacturing process. The needle hub of the current Abboject Syringe is already used as a friction fit for the needle hood.
A protected needle is also disclosed in U.S. Pat. No. 4,834,716 to Ogle. In FIG. 2 of Ogle, the protective sheath is fixed to the needle hub of the syringe. As previously discussed, fixing a protective sheath to the needle hub as suggested by Ogle does not allow a needle hood to be attached to the hub of the standard Abboject syringe as currently manufactured.
Since the Abboject Syringe system has many uses in the healthcare field, any changes to the syringe configuration must not prevent or encumber the various uses, but should enhance the syringe's safe use.
Therefore it is desirable to provide a prefilled syringe system that decreases the risk of accidental needle stick yet is readily adaptable to the various configurations for use in the different infusion and/or connection procedures currently needed in a healthcare facility, such as a guarded needle, a sharp needle, a luer connection, or a blunt cannula connection.
Furthermore, it is desirable that the protection and safety features are compatible with the standard prefilled syringes currently manufactured and in the healthcare inventory. For example, any new syringe configuration should continue to be compatible and interchangeable in use with the Lifeshield Abboject Syringe with Guarded Needle for connection to resealable access sites on I.V. sets. Compatibility is desired so as to providing continuity, economy and flexibility in managing syringe inventory and costs by the healthcare institutions.
It is desirable to provide a prefilled syringe for use as a guarded sharp needle syringe, as an unguarded sharp needle syringe, as a luer connection syringe and as a blunt cannula syringe.
It is desirable that the various connection and needle components be already assembled to the prefilled syringe so that the syringe is ready for use without having to add components during an emergency procedure. Rather, the adapter assembly should provide components that are preassembled and easily removed if not needed.
It is desirable that the health care worker can make either a guarded needle connection or an unguarded needle connection by only having to remove a selected cover element.
It is therefore a primary object of the present invention to provide a multiple use adapter assembly for the Abboject Syringe system so as to facilitate easy use in an emergency situation and to protect the healthcare provider from accidental needle stick.
It is another object of the present invention to add the multiple use adapter assembly to presently manufactured Abboject Syringes so that the adapted syringes may be used interchangeable with the current connection devices in use.
It is another object of the present invention to protect the sterile sharp needle, the luer adapter fitment, and the blunt cannula connection from contamination prior to use.
It is another object of the present invention to provide easy and safe conversion of a prefilled syringe and especially an emergency syringe to the desired connection configuration.